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The purpose of this study is to investigate how mild, noninvasive electrical brain stimulation affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people that stutter. The long-term goal of this study is to test the therapeutic potential of transcranial alternating current stimulation (tACS) for the treatment of stuttering.
The study team hypothesizes that if stuttering involves impaired initiation of motor programs, delta-tuned tACS will strengthen communication between brain regions and decrease stuttering. Therefore, delta-tuned sensorimotor tACS will be paired with fluency-induced speech (choral reading), which is hypothesized to decrease stuttering via improved auditory motor integration.
Participants will have screening and baseline visits that include a variety of tests and procedures (i.e. standardized tests of speech, language, hearing test, music training questionnaire, working memory tests, and speech sample to characterize stuttering, magnetic resonance imaging (MRI) and electroencephalography (EEG)). Following these, participants will have 3 sessions (active and sham conditions) and then a one month follow-up phone or video call.
Of note, there will be an embedded pilot study to refine the experimental protocol in terms of practicality and feasibility and these participants will not be included in this registration. The only purpose of this embedded study is to refine the protocol and it does not have any health or behavioral outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transcranial alternating current stimulation (tACS) | Experimental | Participants will receive 3 sessions of tACS. Each session can be active or sham. The stimulation parameters regarding the active and sham will not be disclosed at this time to maintain blind to participants. At the end of the trial the study will be updated to list these. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial alternating current stimulation (tACS) | Device | During each of the 3 stimulation visits, participants will be seated in a comfortable position and a cap will be placed on participant's head similar to a swimming cap. Small electrodes will be placed near the surface of the scalp at certain regions of interest, and a weak electrical current will be passed through the electrodes into speech related brain areas for 20 minutes. The study team will not use current strengths exceeding 2 milliamps (mA). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Phase Synchronization | The study will compare EEG data recorded before and after stimulation to determine if tACS contributed to any changes. This will be measured by Phase Locking Value (PLV; measured from 0 to 1) between the two regions targeted by stimulation calculated as [pre(active-sham)] - [post(active-sham)] at each tACS visit. | Baseline (pre-tACS), approximately 3 hours (post-tACS) (visits 3-5) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of stuttered syllables produced during speech sample | The study will calculate the percentage of stuttered syllables (out of total syllables) in a speech sample. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering). | Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in perturbation response | The study will compare the perturbation task from before and after tACS. This is measured by the percent change in perturbation response. | Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5) |
| Change in Phase Amplitude Coupling |
Inclusion Criteria for stutterers:
Exclusion Criteria for stutterers:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo-Eun Chang, PhD | Contact | 734-232-0300 | sooeunc@umich.edu | |
| Emily Garnett, PhD | Contact | 734-232-3371 | emilyog@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Soo-Eun Chang, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D013342 | Stuttering |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Participants will all receive the same treatments, however, visits 3 through 5 will have order of conditions (types of stimulation) randomized.
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Please note that because the most logical interventional study model is a single arm study the study team can't select a masking option. Please note that Participants, Investigators, and Outcomes Assessors will be blinded to active vs. sham stimulation (with the exception of one study investigator that pre-configures the randomization schedule, and this person will not be involved in any assessments/outcomes).
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The study will compare EEG data recorded before and after stimulation to determine if tACS contributed to any changes. Phase Amplitude Coupling (PAC) will be calculated within and between the two regions targeted by stimulation calculated as [pre(active-sham)] - [post(active-sham)] at each tACS visit. |
| Baseline (before tACS), approximately 3 hours (post-tACS) (visits 3-5) |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |